Michael Tomasovich

Quality and Regulatory Affairs Consultant @Clinical Partners Group

Livonia, MI, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Aug 2021 — Present

Quality and Regulatory Affairs Consultant @Clinical Partners Group

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Santa Monica, CA, US

Regulatory consultant to various clinical and medical device projects. 510k remediation, FDA pre-sub meetings, RTA responses, 510k submissions, and justifications.

EDUCATION

1989 — 1991

Montcalm Community College

Associate's degree, General Studies

2003 — 2005

Eastern Michigan University

BS, Paralegal Studies

2008 — 2009

Northeastern University

MS, Masters of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices

SKILLS

MicrobiologyHardware Diagnostics510 KOncologyManagementPharmaceuticalsRegulatory RequirementsIndU.s. Food and Drug Administration (Fda)CtmsMedical DevicesClinical ResearchCapaDrug DevelopmentGcpBiopharmaceuticalsRegulatory SubmissionsLeadershipGlpLife SciencesStrategic PlanningRegulatory RiskCROCommercialization21 Cfr Part 11RegulationsClinical TrialsClinical DevelopmentTechnology TransferQuality ControlGmpCross-Functional Team LeadershipRegulatory AffairsLifesciencesValidationPatentsNdaBusiness DevelopmentStart-UpsBiochemistry

ABOUT MICHAEL TOMASOVICH

A regulatory affairs professional consultant dedicated to diligently assisting companies and individuals with the development and approval of therapeutics and medical devices at FDA and around the world.Specialties: IND, NDA, BLA, 510K, and PMA submissions; pre-Submission meeting requests and attendance; regulatory product analysis and strategic development; UDI compliance; labeling and promotional material review; QSR development; 21 CFR Part 11 compliance.

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